Just to follow up on this thread now that the results have been published.
To quote the conclusion below (I’ve expanded some abbreviations to speed up reading):
Conclusions: Adjuvant Everolimus improved Risk Free Survival in Renal Cell Carcinoma patients after nephrectomy, but the nominal significance level was narrowly missed. The Risk Free Survival improvement was seen despite a high rate of early treatment discontinuation. A 21% improvement in Risk Free Survival with Everolimus was observed in patients with very high-risk disease, a group for whom adjuvant therapy may be most relevant.
Also potentially worth quoting this section of the results:
Median Risk Free Survival was not reached; the 6-year Risk Free Survival estimate was 64% for Everolimus and 61% for Placebo. Risk Free Survval improvement with Everolimus vs. Placebo was observed in the very high-risk group (HR 0.79, 95% 0.65-0.97; P1-sided= 0.011) but not in the intermediate high-risk group (HR 0.99, 95% CI 0.73-1.35, P1-sided= 0.48) (P for interaction = 0.22). With 290 deaths, Overall Survival was similar between arms (HR 0.90, 95% CI, 0.71 – 1.13; P1-sided= 0.178).
My initial interpretation is that it’s a disappointing result.
Any other takes on this? @MAC @RapAdmin
One thought that does occur to me, is that we know immune suppression occurs with chronic doses of rapamycin. In this study they were using 10mg of Everolimus daily, split morning and evening.
Would it not make sense to pulse the dose (as is being done for longevity) to give their immune system a better chance to suppress future cancer? Afaik we all rely on our immune systems to suppress cancer all the time. Also, presumably the compliance rate would be higher?
To quote the studies compliance rate:
Fewer patients completed all 54 weeks of study treatment in the Everolimus group (45% v 69%)
I interpret that to mean 45% of the Everolimus group completed all 54 weeks, compared to 69% of the placebo group?